Loading clinical trials...

Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia

A Phase II, Multi-Center Open-Label, Repeat-Dose of Forodesine Hydrochloride (BCX-1777) Infusion in Patients With Advanced T-Cell Leukemia With an Option of Long-Term Forodesine Hydrochloride (BCX-1777) Use

NCT00095381•BioCryst Pharmaceuticals

View on ClinicalTrials.gov

Summary

BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Phase II trial is designed to study the effectiveness of BCX-1777 in treating patients who have recurrent or refractory advanced T-cell leukemia. Patients will receive an infusion of BCX-1777 on days 1-5. Treatment may be repeated every week for up to six courses. Patients are not required to be hospitalized for the administration of BCX-1777. Some patients may continue to receive an infusion of BCX-1777 twice a week for 6 weeks.

Detailed Description

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented T-cell leukemia (precursor T-lymphoblastic leukemia/lymphomia or T-PLL)
•Failure to have responded to one or more standard regimens for their disease.
•Performance status of \<=2 by Eastern Cooperative Oncology Group (ECOG) criteria
•All ages are eligible
•Life expectancy of at least 3 months
•Adequate liver function (aspartate transaminase \[AST\] and/or alanine transaminase \[ALT\] not \>3 times upper limits or normal \[ULN\])
•Adequate kidney function (calculated creatinine clearance \>50 mL/min)
•Negative urine pregnancy test within 2 to 7 days prior to the start of study treamtment in females of childbearing potential
•Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study
•Signed informed consent/assent form (ICF) prior to start of any study specific procedures

Exclusion Criteria

•Patients with known HIV infection or human T-cell leukemia virus type (HTLV-1)
•Patients with known Hepatitis B and/or Hepatitis C active infection
•Patients with active CMV infection
•Tumor-related central nervous system (CNS) leukemia requiring active treatment
•Active serious infection not controlled by oral or IV antibiotics
•Treatment with any investigational anti-leukemic agent or chemotherapy agent within 7 days prior to study entry, unless full recovery from side effects has occurred.
•Rapidly progressive disease with compromised organ function judged to be life-threatening by the investigator
•Concurrent treatment with other anticancer agents (corticosteroid use will not be excluded, but patient must remain on the stable dose)
•Cutaneous T-cell lymphoma (CTCL) diagnosis (including Sezary Syndrome)
•Pregnant and/or lactating women

Locations (24)

Los Angeles, California, United States

Palo Alto, California, United States

Denver, Colorado, United States

Gainesville, Florida, United States

Lecanto, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Kansas City, Kansas, United States

New Orleans, Louisiana, United States

Key Dates

Start Date

March 1, 2004

Primary Completion Date

March 1, 2007

Completion Date

December 1, 2007

Last Updated

January 19, 2012

Enrollment

Estimated participants

Conditions

Leukemia, T-Cell

Interventions

forodesine hydrochloride (BCX-1777)

DRUG